Kornimate/medical-research-clean huggingface dataset:
safety and electrical performance evaluation of invicta leads models equipped with df4 connector

Conditions: Ventricular Arrythmia; Lead; ICD; Heart Failure

Summary: the primary objective of this study is to assess the safety and key electrical performance of the invicta leads equipped with df4 connector: active fixation type models (single and dual coil: invicta 1cr, invicta 2cr) and passive fixation type models (single and dual coil: invicta 1ct, invicta 2ct).

friends study is a pre-market approval (invicta leads - devices under investigation - are not ce marked), interventional, prospective, longitudinal, international (european), multicenter, single arm study. the devices under investigation, the invicta defibrillation leads, are new quadripolar leads, to be used with implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators (icd/crt-d). this clinical study intends to demonstrate safety and electrical performances of the invicta leads among the different models: active fixation either single coil (model 1cr) or dual coil (model 2cr) and passive fixation, either single coil (model 1ct) or dual coil (model 2ct) leads models. the clinical data will be used to support the application to ce marking of invicta leads. the primary endpoints will be evaluated at 3 months post-implantation; secondary endpoints will be evaluated up to 2 years post-implantation. a maximum number of 224 patients will be enrolled in the study, in up to 60 centers in europe. the follow-up visits are scheduled at hospital discharge, at 1 month, at 3 months, at 6 months, at 12 months, at 18 months and at 24 months, post-implant .

Eligibility criteria:
inclusion criteria: 1. any patient presenting an icd or crt-d indication as detailed in the latest european society of cardiology (esc) guidelines 2. scheduled for a primary implant of an icd / crt-d, manufactured by microport crm and equipped with a rv df4 connector 3. signed and dated informed consent exclusion criteria: 1. tricuspid valvular disease or tricuspid replacement heart valve (mechanical or tissue) 2. transient tachyarrhythmias due to reversible causes (such as drug intoxication, electrolyte imbalance, sepsis, hypoxia or other factors as myocardial infarction or electric shock) 3. contraindication to a maximum single dose of 330 µg dexamethasone sodium phosphate (dsp) 4. active myocarditis 5. already included in another clinical study that could confound the results of this study 6. inability to understand the purpose of the study or to meet follow-up visits at the implanting centre as defined in the investigational plan 7. patient less than 18 years old or under guardianship or kept in detention 8. known pregnancy, women in breastfeeding or in childbearing age without an adequate contraceptive method 9. drug addiction or abuse

Keywords: invicta lead icd crt-d microport
study of ibi323 in patients with advanced malignancies

Conditions: Advanced Malignancies

Summary: the purpose of this study is to evaluate safety, tolerability and efficacy of ibi323(anti-lag-3/pd-l1) or in combination with chemotherapy in participants with advanced malignancies. another purpose is to determine the pharmacokinetics,pharmacodynamics and immunogenicity of ibi323


Eligibility criteria:
inclusion criteria: 1. phase ia patients with locally advanced, recurrent or metastatic solid tumors who have failed standard treatment phase ib cohort a patients with io-refractory advanced nsclc cohort b patients with io-naive advanced nsclc who have failed standard treatment cohort c patients with advanced nsclc who have no prior treatment and pd-l1 tps≥1% cohort d patients with es-sclc or g3 neuroendocrine tumors who have failed standard treatment cohort e patients with advanced mpm who have failed standard treatment cohort f patients with advanced uc who have failed standard treatment cohort g patients with advanced nccrcc who have failed standard treatment cohort h patients with advanced hcc who have failed standard treatment cohort i patients with advanced npc who have failed standard treatment cohort j patients with advanced cc or hnscc who have failed standard treatment cohort k patients with advanced gc or gejc with her2 negative who have no prior treatment cohort l patients with advanced tnbc who have failed standard treatment 2. able to understand and willing to sign the icf. 3. 18 to 75 years old. 4. life expectancy at least 12 weeks. 5. at least 1 measurable lesion per recist v1.1. 6. eastern cooperative oncology group (ecog) performance status of 0 or 1. 7. adequate organ and bone marrow functionadequate organ and bone marrow function. exclusion criteria: 1. prior treatment with any anti- lag-3 antibody. 2. prior immunotherapy treatment for stage ia extension cohort ( immunotherapy untreated) and stage ib cohort b-l 3. any investigational drugs received within 4 weeks prior to the first study treatment. 4. receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy. 5. symptomatic cns metastasis. 6. history of autoimmune disease , present active autoimmune disease or inflammatory diseases 7. pregnant or nursing females.
oncology-patient-reported anxiety, mood, and qol during the covid-19 pandemic

Conditions: Cancer

Summary: oncovid is a prospective cohort study investigating oncology-patient-reported anxiety, mood, and quality of life during the covid-19 pandemic. participants complete a survey consisting of sociodemographic information and self-administered questionnaires (covid-19 peritraumatic distress index, depression anxiety stress scale-21, and who quality of life-bref). data collection occurs at baseline and follow-up surveys are performed after 6, 12, and 24 weeks.


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * histologically confirmed cancer * receive systemic therapy (including chemotherapy, targeted small-molecule therapy, anticancer monoclonal antibody, immunotherapy, endocrine therapy, or investigational agent) (either exclusively or in combination with other anticancer therapy) between february 14, 2020 and march 31, 2020 (note: patients whose systemic treatment administration was initially planned for this period but was modified, delayed, stopped, or withheld due to covid-19 measures are also eligible for inclusion) exclusion criteria: * insufficient understanding of the dutch language * severe cognitive impairment * acute psychiatric crisis * not able to give informed consent * confirmed or clinically suspected covid-19 * endocrine therapy in (neo)adjuvant setting (note: patients whose (neo)adjuvant systemic treatment was initially planned as chemotherapy, targeted small-molecule therapy, anticancer monoclonal antibody, immunotherapy, or investigational agent (either exclusively or in combination in combination with other anticancer therapy) but was modified to endocrine therapy due to covid-19 measures are also eligible for inclusion)

Keywords: covid-19 quality of life anxiety stress mood dass-21 whoqol-bref cpdi
effectiveness of insoles provided to patients with diabetes. a longitudinal randomized controlled study in gothenburg

Conditions: Diabetic Foot; Neuropathy; Quality of Life

Summary: introduction: insoles and shoes are frequently prescribed to prevent foot ulcers in patients at risk of diabetes. a combination of neuropathy and foot deformities raises the risk from 1% to between 4-7% according to the swedish national board of health and welfare, guidelines diabetes care 2010. preventative care, which includes foot care, annual inspection of the feet, education and prescription of insoles in combination with well fitting shoes are supposed to decrease the risk of ulcers and prevent amputation. further research is, however, needed to evaluate the effectiveness of these commonly prescribed insoles. the aim of this study is to compare three different types of insoles with respect to pressure distribution. every 6 months follow-up is assessed until 24 months is reached.

patients included in the study were randomized into 3 different groups. group number 1 and 2 got custom made insoles out of eva (ethyl vinyl acetate) with different hardness 35 and 55 shore respectively. group nr 3 got prefabricated insole with support of the medial arch and in the forefoot. the top layer was covered with a 2 mm cushioned material, 25 shore, made out of microcellular urethane. all patients were recommended to wear good walking shoes with a semi rigid outer sole and stable heel counter. one and the same technician made the casting and fabricated the insoles as well as delivered the devices. deliverance occured 2-3 weeks after the first visit. at deliverance base line measurement was assessed.

Eligibility criteria:
inclusion criteria: * first time visitor to dept of prosthetics \& orthotics * diabetes * age \> 18 year * be able to walk independently * be able to read and understand swedish exclusion criteria: * ulcers

Keywords: diabetic foot offloading prevention orthotics
physiotherapy technique decreases respiratory complications after cardiac operation

Conditions: Pneumonia; Pleural Effusion; Atelectasis

Summary: the objective of this study is to assess whether there is a difference between a care protocol with the use of incentive spirometry (voldyne ®) and another with the application of niv (non invasive ventilation with single-level pressure) as a form of therapy. the main focus of the study is to determine the incidence of pulmonary complications in each technique.

coronary artery bypass graft (cabg) can prolong and improve the quality of life of patients with ischemic coronary syndrome but with the advancement of medical intervention to eligible patients for this procedure are those with more comorbidities where conservation and palliative therapies have been tried without success. patients undergoing cabg often develop pulmonary complications such as atelectasis, restrictive ventilatory defect, decreased lung compliance, increased shunt and changes in gas exchange leading to probable hypoxemia. in an attempt to reduce the harmful effects and pulmonary complications arising from surgical procedures is instituted extensive physiotherapy program that tracks and monitors such patients from the preoperative to the postoperative immediate transfer to the ward and hospital discharge. the objective of this study is to assess whether there is a difference between a care protocol with the use of incentive spirometry (voldyne ®) and another with the application of niv (non invasive ventilation with single-level pressure) as a form of therapy. the main focus of the study is to determine the incidence of pulmonary complications in each technique.

Eligibility criteria:
inclusion criteria: * patients with indication for elective coronary artery bypass surgery who agreed to participate and signed the informed consent. exclusion criteria: * patients with hemodynamic instability during the physiotherapy care * those who fail to complete all visits to the proposed protocol (whatever the reason) * extubation after 12 hours of icu admission * major intraoperative hemorrhage * major bleeding in icu requiring return to the operating room * cardiopulmonary arrest * contraindication to positive pressure (undrained pneumothorax, bronchopleural fistula, hemoptysis, vomiting) or intolerance to the method

Keywords: continuous positive airway pressure cough oxygen inhalation therapy
pet avidity in cachexia-inducing lung and gastrointestinal tumors

Conditions: Cachexia; Cancer

Summary: pet has an established role in the initial staging of patients with newly diagnosed lung and gastrointestinal tumors.pet avidity is described with both maximum and mean standardized uptake values.malignant cells have increased activity on pet, defined as the standardized uptake value (suv), with increased uptake of fdg in tumor due to elevated levels of glut receptors, elevated intracellular levels of hexokinase and increased rates of glycolysis. however, there is a subset of patients with lung and gastrointestinal tumors that are not pet avid.these patients may present with clinically and systemically aggressive disease with a declining performance status and/or weight loss.

this study will be a retrospective review of patients in the tumor registry with lung and gastrointestinal tumors, not limited to but including small and non-small cell lung cancers, stomach cancer, small intestinal cancer, colon cancer, rectal cancer, liver and intrahepatic bile duct cancers, gallbladder and extrahepatic bile duct cancers, and pancreatic cancer. there will be a maximum of 10,000 charts/records that will be reviewed to compile the data. data to be collected will include patients' name, medical record number, date of birth, race, ethnicity, gender, medical history, medications, vital and performance status, vital signs including weight and body mass index, date of cancer diagnosis, clinical and pathologic stage, pathology, treatment course, prior treatment, location of primary lesion, and smoking history. ct and pet findings to be reviewed include the number of involved lymph nodes, size of primary tumor, average/maximum pet avidity in both the primary tumor and involved lymph nodes.

Eligibility criteria:
inclusion criteria: patients with histologically proven lung and gastrointestinal cancers, stages i-iv with pet and/or ct within 6 weeks of diagnosis. exclusion criteria: there will be no absolute exclusion criteria as long as the inclusion criteria have been met.
improving performance in drivers with mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: the objective of this study is to assess the effectiveness of an intervention to address both executive function and processing speed changes that contribute to poor driving performance in adults with mild cognitive impairment (mci). our hypotheses are that the study intervention will improve performance on a driving simulator and will improve (i) executive function, specifically attention and planning, (ii) useful field of view, (iii) mood, (iv) quality of life, and (v) reported motor vehicle crashes and driving infractions.

executive function and processing speed are recognized critical correlates of driving performance and have been shown to decline in older adults and in persons with mild cognitive impairment. members of our research team have shown that group executive function training such as goal management training results in benefits for healthy older adults, including improved simulated daily activities. the ultimate purpose of our research is to develop interventions to help maintain older adults' mobility in order to assist their 'aging at home'. the planned study will assess the effectiveness of an intervention that includes goal management training + processing speed training (using drivesharp software), which is designed to address both executive function and processing speed changes that contribute to poor driving performance in people with diagnosed mild cognitive impairment. the investigators will measure the effectiveness of the intervention on driving performance, sustained attention, divided attention, executive function, depressive symptoms and quality of life.

Eligibility criteria:
inclusion criteria: * mild cognitive impairment * currently driving or voluntarily stopped driving within the past year * fluent in english exclusion criteria: * visual problems that cannot be corrected with standard lenses * alcohol/substance abuse * stroke with residual motor /sensory deficit * traumatic brain injury * seizure in the past two years * parkinson's disease * multiple sclerosis * untreated sleep apnea * history of motion sickness * history of dizziness, vertigo * active primary psychiatric disorder requiring treatment * on a dose of cognitive enhancing medication for less than 3 months

Keywords: mild cognitive impairment seniors cognitive training driving driving simulation intervention goal management training process speed training
a double-blind study to assess 2 doses of an investigational product for 16 weeks in participants with non-alcoholic fatty liver disease and type 2 diabetes mellitus

Conditions: Non-alcoholic Steatohepatitis

Summary: this is a double-blind, placebo-controlled study in adults with non-alcoholic steatohepatitis and type 2 diabetes mellitis on stable dose of metformin monotherapy. participants will be treated for 16 weeks with placebo or 1 of 2 doses of investigational product to determine the effect on liver fat, hba1c, safety, tolerability and pharmacodynamics.


Eligibility criteria:
inclusion criteria: * males, or females of nonchildbearing potential * 18 to 70 years of age * type 2 diabetes mellitus * liver fat \>/=8% by mri-pdff * on stable dose of metformin monotherapy for at least 2 months (at a dose of at least 500 mg daily) exclusion criteria: * history of other liver disease * unable to have an mri performed * significant weight loss in the previous month and/or participant in current weight loss program * history of diabetic complications with end-organ damage

Keywords: non-alcoholic steatohepatitis; type 2 diabetes mellitus
evaluating the efficacy of fenestrations in tube shunt implants during the early postoperative period

Conditions: Glaucoma

Summary: this study evaluates two different methods of controlling intraocular pressure in nonvalved aqueous tube shunts immediately after implantation; needle fenestrations or a suture wick.

this is a prospective, randomized control study of glaucomatous eye undergoing tube shunt implantation using a nonvalved implant for poorly controlled glaucoma of any type. eyes scheduled to receive a nonvalved tube shunt implant will be randomized to receive either needle fenestration(s) or a suture wick using a single 10-0 vicryl anterior to the ligature. the operative quadrant will be imaged using anterior-segment optical coherence tomography at pre- and post-operative visits.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * eyes that have poorly controlled glaucoma requiring a tube shunt implantation * willingness to participate in the study and sign informed consent exclusion criteria: * concurrent surgery except phaco/intraocular lens * any abnormality preventing reliable applanation tonometry * eyes with exposure limitation (tight lids, deep orbits) that would make performing the anterior segment optical coherence tomography difficult
addition of heparin to taurolock-tm cls in hd patients with tcc dose it improve catheter patency problems ?

Conditions: End Stage Renal Disease; Hemodialysis

Summary: addition of heparin to the catheter lock solution (cls): taurolock-tm will improve the vascular patency compared to taurolock-tm alone , in hemodialysis patients with tunneled cuffed catheter(tcc) as vascular access.

bacteremia and thrombosis are the major complications of tcc used for hemodialysis.instilation of cls containing antibiotic-anticoagulant solution in the end of each dialysis session till the next dialysis ,can prevent catheter related bacteremia (crb).in previous study in our department, taurolock-tm decreased the rate of crb but increased the incidence of catheter malfunction. the aim of the study is to investigate the influence of of heparin addition to cls-taurolock- tm ( taurolidine \&citrate 4%) in prevention of catheter patency problems in hd patients with tcc, in addition to crb prevention. methods : patients with newly inserted tcc for hd enrolled and randomized to receive one of three cls types : group 1- taurolock-tm, group 2 - taurolock-tm and heparin , group 3- heparin .patients were followed for 6 monthes. the objective of the study is to investigate the effect of taurolock tm with heparin on the rate of crb and vascular patency.

Eligibility criteria:
inclusion criteria: * hemodialysis patients with new tcc * informed consent

Keywords: tunneled cuffed catheter catheter lock solution catheter related bacteremia
open-label study for shoulder dislocation using mg-1

Conditions: Shoulder Dislocation

Summary: to evaluate the efficacy and safety of arthroscopic bankart repair using mg-1 for dislocation of shoulder


Eligibility criteria:
inclusion criteria: * patients with dislocation of the shoulder and indicated for arthroscopic bankart repair * patients of 16 years or older * patients who understand the contents of the study and from whom a written consent can be obtained * patients who can visit the hospital for follow-ups after surgery exclusion criteria: * patients with serious complications * patients with comminuted fracture which may prevent fixation of the anchors * patients with the following diseases or conditions which may delay healing 1. lack of blood, infection, etc. 2. psychiatric disorder, alcohol poisoning, drug toxicity, etc. 3. tissues around the surgical site are not healthy under steroid therapy or chemotherapy * patients with epilepsy or bone disease (cystic change, osteopenia, etc.) * patients with dementia * patients with a history of allergy to glycolic acid, poly-l-lactic acid, β-tricalcium phosphate, polyethylene or polydioxane * patients who cannot undergo general anesthesia * patients who cannot undergo plain x-ray examination or mri examination * patients with previous bone grafting in the shoulder joint * patients who participated in another clinical trial within past 3 months * patients who are pregnant or lactating. patients who plan to be pregnant within a year * patients judged to be inappropriate for the study by the (sub)investigator

Keywords: arthroscopic bankart repair suture anchor shoulder dislocation
endoscopic treatment of salivary glands affected by sjögren's syndrome

Conditions: Sjögren's Syndrome

Summary: sjögren's syndrome (ss) is an autoimmune inflammatory disorder of the exocrine glands. it particularly affects the lacrimal and salivary glands. severe dry mouth and eyes are frequently reported as presenting symptoms. these symptoms are in many cases accompanied by nonspecific symptoms, such as malaise and fatigue. in addition, extraglandular manifestations, like purpura, polyneuropathy, and arthritis, can be present. ss affects mainly women with a female/male ratio of 9:1 and can occur at all ages. due to the irreversible damage to the saliva producing cells, the quantity and quality of saliva reduces. the progressive nature of the syndrome results in a further reduction of salivary flow. due to hyposalivation the patients suffer from progressive dental decay, dental erosion, severe dry mouth complaints (i.e. eating and swallowing problems, lack of taste), inflammation of the oral mucosa and lack of retention of removable dentures. overall, this can be qualified as a reduction in the quality of life. until now no effective (palliative) therapy to relieve dry mouth complaints is available. a recent case series study suggests that an endoscopic technique (sialoendoscopy) is able to alleviate the symptoms of patients suffering from ss. in this technique the ducts of the salivary glands are rinsed with saline and cortisone and possible strictures are dilated. it is hypothesised that performing a sialoendoscopic treatment will raise or restore (un)stimulated salivary flow levels and improve the reported mouthfeel score.


Eligibility criteria:
inclusion criteria: * a diagnosed (by the european league against rheumatism guidelines) primary or secondary syndrome of sjögren * age: \> 18 years and \< 70 years * a remaining salivary flow exclusion criteria: * a complete lack of measurable salivary flow, also after stimulation of the glands by taste or chewing * acute sialadenitis * use of sialogogue medication (i.e. pilocarpine or cevimeline) * other severe illnesses or physical conditions that make a treatment under general anesthesia impossible or highly riskful.

Keywords: sjögren's syndrome sialoendoscopy saliva dry mouth